Synthesis, Process Optimization, and Scale-Up
By integrating optimized synthesis, efficient purification platforms, and proactive scale-up risk assessments, we compress development timelines and prevent costly late-stage delays while significantly reducing your overall Cost of Goods (COGS).
Synthesis Optimization
Maximizing reaction yield drastically reduces raw material consumption. Optimizing enzyme loading and careful selection of critical raw materials lowers per-batch costs, while minimizing impurities & reduces the burden on downstream steps.
Downstream Process (DSP) Optimization
Improving yield and recovery during purification reduces the upstream batch size needed to meet targets, causing a multiplicative reduction in material and labor costs. Extending chromatography resin life and simplifying purification steps further slashes expenses.
Scale-Up
Proactive scale-up risk assessments and scale-down modeling identify problems before technology transfer, preventing clinical holds and regulatory delays that typically cost programs 12 to 18 months. Establishing a scalable process early avoids the need for highly disruptive and expensive late-stage process redesigns.
Let us help maximize your impact.
Smart molecule design is critical for execution!
Our strategy is built for robustness, success and speed. The correct design strategy saves time and decreases wet lab experiment design space, enables faster synthesis and scale up optimization to accelerate development freeing up your resources. Reduction of royalty and licensing costs and avoid common pitfalls. Reduced COGs and longer-term strategy baked in to ensure compliance with regulatory requirements.
Frequently Asked Questions
What are the main goals of your synthesis optimization services?
Our reaction optimization simultaneously focuses on improving purity and yield while reducing costs and the generation of impurities. We also provide expert guidance on biocatalysis, enzyme kinetics, and optimizing enzymatic processes across various protein classes to ensure a robust and scalable process from the start.
Which chromatography and filtration techniques do you utilize for Downstream Process (DSP) optimization?
We design highly efficient purification platform strategies by utilizing affinity, ion exchange, SEC (Size Exclusion Chromatography), mixed-mode chromatography, and TFF (Tangential Flow Filtration) to maximize both product recovery and purity.
How do you mitigate risks when transitioning a process to larger manufacturing scales?
We perform thorough scale-up risk assessments to pinpoint specific process parameters that may behave differently at larger volumes. Furthermore, we advise on development of scale-down models to effectively troubleshoot any issues that arise during this transition.
Do you assist with early-stage regulatory and quality planning during scale-up?
Yes, we provide expert advice on process characterization, which directly leads to the drafting of your initial Quality Target Product Profile (QTPP), bridging gaps from early-stage activities to the clinic/ IND stages.